Identity
- Trade Name
- Alpha™ Acupuncture Needles FDA UDI
- Generic Name
- Acupuncture needle, single-use FDA UDI
- Device Name
- thicker, longer for easy handling and colored bright fluorescent orange for easy locating, no guide tube, 1,000 needles / box FDA UDI
- Model / Reference
- D Type 0.20 x 13 mm FDA UDI
- Description
- thicker, longer for easy handling and colored bright fluorescent orange for easy locating, no guide tube, 1,000 needles / box FDA UDI
Identifiers
- Catalog Number
- NAD-3605 FDA UDI
- Primary DI / UDI-DI
- 00818318025512 FDA UDI
- FDA Product Code
- MQX FDA UDI
- GMDN Term
- Acupuncture needle, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5580 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Acupuncture needle, single-use
Alpha™ Acupuncture Needles by Prime Holly Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Acupuncture needle, single-use.
- Energy Flo Value-Pak J Type Acupuncture Needles — Acu Market · Class II
- ASIA MED — asia-med GmbH · Class II
- CARBO — WuJiang City Cloud&Dragon Medical Device Co., Ltd. · Class II
- STERILE ACUPUNCTURE NEEDLES FOR SINGLE USE — Changchun AIK Medical Devices Co., Ltd. · Class II
- SHUNLI — Wuxi Jiajian Medical Instrument Co., Ltd. · Class II
- AcuZone — Wujiang City ShenLing Medical Device Co., Ltd · Class II
- ASIA MED — asia-med GmbH · Class II
- Millennia Bulk Acupuncture Needle — UPC MEDICAL SUPPLIES, INC. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Prime Holly Corporation
Sources (1)
- FDA UDI e0d02773-af8b-47cf-b3c2-c6350733e5f8 36 fields · synced Jun 6, 2026